CS5001(ROR1 ADC)

Search documents
基石药业-B(02616):下一代IO疗法潜力明显,关注ESMO三抗数据读出
Tianfeng Securities· 2025-08-17 13:46
Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 12.55 per share, indicating an expected relative return of over 20% within the next six months [5][13]. Core Insights - The company is focusing on the potential of next-generation immuno-oncology therapies, particularly the CS2009 (PD-1/VEGF/CTLA-4) which is expected to show promising efficacy and safety data at the upcoming ESMO conference [2]. - The sales of Pralsetinib have significantly declined due to price adjustments and one-time channel compensations in preparation for national medical insurance negotiations, but successful inclusion in the insurance directory is anticipated to accelerate sales growth post-2026 [1]. - The clinical pipeline is expanding with multiple candidates, including CS5001 (ROR1 ADC), which is progressing steadily through clinical trials and is expected to broaden its indications [3][4]. Summary by Sections Financial Performance - For the first half of 2025, the company reported revenue of RMB 49.4 million, with a significant decline in Pralsetinib sales due to price adjustments [1]. - The revenue and profit forecasts for 2025-2027 have been adjusted, with expected revenues of RMB 123 million, RMB 829 million, and RMB 1.125 billion, reflecting year-on-year growth rates of -68.25%, 575.37%, and 35.81% respectively [5]. Clinical Development - CS2009 is undergoing a global multi-center I/II clinical trial, with safety and efficacy data expected to be presented at the ESMO conference in October 2025 [2]. - CS5001 is actively recruiting patients for various treatment combinations, showing no dose-limiting toxicities (DLT) thus far, and is expected to expand into Phase II studies [3]. Pipeline Expansion - The company has over nine potential candidates in its preclinical pipeline, focusing on multi-specific antibodies and ADCs, which cover oncology, autoimmune, and inflammatory diseases [4].
基石药业-B(02616.HK):将在ESMO大会上首次披露CS2009临床数据与CS5001最新研究设计
Ge Long Hui A P P· 2025-07-30 06:16
格隆汇7月28日丨基石药业-B(02616.HK)发布公告,2025年10月17日至21日,全球最具影响力的肿瘤学 会议之一,欧洲肿瘤内科学会(ESMO)大会将在德国柏林召开。基石药业将在ESMO大会上公布研发 管线2.0重磅产品CS2009(PD1/VEGF/CTLA-4三特异性抗体)的最新临床研究数据和CS5001(ROR1 ADC)的全球多中心Ib期研究设计。 CS2009是一款潜在同类首创/同类最佳的三特异性抗体,其全球多中心I期剂量递增和剂量扩展研究正在 澳大利亚和中国积极招募患者,并计划扩展至美国进行II期入组。基石药业将在ESMO大会上公布 CS2009的Ia期临床研究数据,这也将成为全球首批关于PD1/VEGF/CTLA-4三特异性抗体的临床数据报 告。 CS5001是目前已知首个在淋巴瘤和实体瘤中均观察到临床疗效的ROR1 ADC,其临床开发进展位于全 球前二。目前,CS5001的全球多中心Ib期临床试验正在美国、澳大利亚和中国同步推进。基石药业将 在ESMO大会上公布正在进行的Ib期研究设计。 ...